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OpenTrials
Completed

NCT Number: NCT00698802

Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vijayawada, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes for at least 12 months
  • Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2
  • HbA1c less than or equal to 9.5%
  • FPG (SMPG) less than or equal to 12 mmol/L

Exclusion criteria

  • Treatment with more than 1IU/kg insulin daily
  • Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial products or related products
  • Receipt of any investigational drug within one month prior to this trial
  • Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers

Treatment and study plan

EX1000

Drug

Treat-to-target titration scheme, s.c. injection

biphasic human insulin

Drug

Treat-to-target titration scheme, s.c. injection

Primary outcomes

  1. HbA1c

    Time frame: after 8 weeks of treatment

Secondary outcomes

  1. HbA1c

    Time frame: For the duration of the trial

  2. Fructosamine

    Time frame: For the duration of the trial

  3. FPG

    Time frame: For the duration of the trial

  4. 4-point SMPG profiles

    Time frame: For the duration of the trial

  5. Incidence of hypoglycaemic episodes

    Time frame: For the duration of the trial

  6. Frequency and severity of adverse events (including injection site reactions)

    Time frame: For the duration of the trial

  7. Laboratory safety parameters (haematology, biochemistry and lipids)

    Time frame: For the duration of the trial

  8. Physical examination and vital signs

    Time frame: For the duration of the trial

  9. Total daily insulin dosages

    Time frame: For the duration of the trial

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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